National Clinical Audit of Psychosis (NCAP)

Healthcare Quality Improvement Partnership (HQIP) requires access to NHS England data for the National Clinical Audit of Psychosis (NCAP) Early Intervention in Psychosis (EIP) routine data audit.

HQIP has commissioned The National Clinical Audit of Psychosis (NCAP) on behalf of National Clinical Audit and Patient Outcomes Programme (NCAPOP) to undertake the work and is involved in decisions about the processing of the data.

The following is a summary of the aims of the NCAP audit provided by the Controller:

NCAP aims to improve the quality of care that NHS mental health services provide to people with psychosis. This is achieved by accessing the Mental Health Services Data Set (MHSDS) to use data as an indicator of performance for the NCAP standards, thus providing high quality audit data on NHS care to those who commission, deliver and use services for people with psychosis.

With the support of colleagues in NHS England, the Royal College of Psychiatrists (RCPsych) aim to move from a system that relies on clinical teams entering pseudonymised data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England routinely submit to NHS England as part of the MHSDS. The Pilot audit will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team.

Around 10% of NHS-funded EIP teams in England have been recruited to take part in the pilot audit. It is expected that all eligible patients will be included within the sample. The cohort consists of people with first episode psychosis aged 65 and under who are on the caseload of:

• NHS funded Early Intervention in Psychosis (EIP) teams in England or

• NHS-funded Children and Young People’s Mental Health/Child and Adolescent mental health services in England where EIP teams do not extend their offer to children and young people.

The data collected by RCPsych for the audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the pseudonymised data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit. Only pseudonymised data will be compared so there will be no risk of re-identifying individuals.

The following NHS England Data will be accessed for the national rollout of the routine EIP pilot audit:

Mental Health Services Data set (MHSDS), necessary for comparing data collected as part of the case-note audit with data from MHSDS.

The following NHS England Data will be accessed for the National Audit:

· Mental Health Services Data set (MHSDS) necessary for analysing the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• The cohort consists of patients aged 65 and under with First Episode Psychosis (FEP) or At Risk Mental State (ARMS) on the caseload of an EIP team for 1 year or more at the date of data extraction and are still on the caseload.

• Limited to a study cohort identified by NCAP 'Care Professional Team Local ID'

• Pilot cohort study size ~10560

• National Audit data limited to MHSDS data from 2020/21-2023/24 annual data. Then quarterly drops of MHSDS data only for the pilot audit during this version of the Data Sharing Agreement.

The dataset required for the pilot audit will be compiled by the RPCsych member of staff under honorary contract at NHSE, consisting of only those data fields relevant to the NCAP audit measures which will be finalised during the completion of the pilot audit. The dataset will reflect the national eligible sample, identified using Care Professional Team Local ID.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

The lawful basis for NHS England processing special category data under the UK GDPR is:

Article 9(2)(h) Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3.

The Data are requested for reasons of management of Health and Social Care Systems and Services - meeting the conditions in the DPA 2018 Schedule 1 Part 1, schedule 2(2)(f).

The conditions and safeguards in DPA 2018 section 11(1) – stating that “For the purposes of Article 9(2)(h) of the GDPR (processing for health or social care purposes etc), the circumstances in which the processing of personal data is carried out subject to the conditions and safeguards referred to in Article 9(3) of the GDPR (obligation of secrecy) include circumstances in which it is carried out—

(b) by another person who in the circumstances owes a duty of confidentiality under an enactment or rule of law.”

NHS England meets this condition because NHS England is subject to a duty to promote a comprehensive health service, designed to secure the improvement in the physical and mental health of people in England and the prevention, diagnoses and treatment of illness, which it discharges alongside the Secretary of State, except for that part of the health service that is delivered in pursuit of public health functions of the Secretary of State or local authorities. (NHS Act 2006, S1H (2)) and NHS England assists Secretary of State in providing health services and exercising public health functions.

Section 12 empowers the Secretary of State to make arrangements with any person or body to provide, or assist in providing, anything that the Secretary of State has a duty or power to provide, or arrange for the provision of, under section 2A or 2B or Schedule 1 of the 2006 Act, as amended (the Secretary of State’s duty as to the protection of public health and the improvement of public health respectively). (NHS Act 2006, S12, HSCA 2012, s22).

HQIP rely on Article 9(2)(i) as the legal basis for processing under the UK GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

National Clinical Audit of Psychosis is funded by HQIP. Funding is in place until 31/7/2025.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

The RCPsych is a processor acting under the instruction of HQIP. The RCPsych have a data processing contracts with Netsolving Ltd who provide the online platform upon which clinical audit data is uploaded and presented.

Data will be accessed by:

• A RCPsych member of staff with an honorary contract to work within NHS England will create a bespoke dataset for the NCAP audit to meet the requirements of the pilot study and wider national rollout of the audit. They will export the pseudonymised data to RCPsych colleagues for upload onto the Netsolving platform to show performance against the audit standards at team, Trust, regional and national level. Pseudonymised record level data will be exported to RCPsych colleagues for support on defining the data required to evidence the audit standards, as well as the export of code for quality assurance testing.

Data processing will be carried out by members of the NCAP team who are all substantive employees of the Royal College of Psychiatrists and as such are required to complete mandatory training on GDPR and data confidentiality.

The NCAP Implementation Group helped refine the purpose of the research. The group strongly supported the collection of the data for the purposes described above. The NCAP implementation group co-ordinates expert and specialist input into audit development and operation.

The expected outputs of the processing will be:

• NCAP Audit Reports

• Online Dashboard to show performance for the EIP audit measures

• Presentations at specific conferences and quality improvement workshops conferences’

• A database to be utilised as a resource for health research

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Workshops involving audit results and quality improvement.

• Webinars

• Social media

• Public reports

• Reports aimed at EIP services; steering group representatives are made publicly available on the NCAP website.

The expected dates for production and dissemination of the outputs will be early 2025.

As the RCPsych have been commissioned to move the audit away from collecting bespoke data to only using the routinely collected data. The only data the RCPsych have received to date was used in the feasibility study in 2022 with the aim of seeing how reliably the NCAP audit data matches to routine data collected on the MHSDS.

The analysis in the report examined the strength of agreement between equivalent data collected from both databases. This has given the NCAP a baseline of how reliably data on the MHSDS can be used to demonstrate audit performance and areas where there is the most need to drive up the quality of reporting.

The National Clinical Audit of Psychosis (NCAP) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with psychosis with high quality data on the process and outcomes of NHS care.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 40 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing.

The programme is funded by NHS England, the Welsh Government and, with some individual projects, other devolved administrations and crown dependencies.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

The Royal College of Psychiatrists (RCPsych) are making an application for access to the Mental Health Services Data Set (MHSDS). This is to carry out a feasibility study into the use of routine data for the audit in the future.

With the support of colleagues in NHS England, RCPsych are aiming to move from a system that relies on clinical teams entering pseudonymised data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England already submit to NHS England as part of the MHSDS. The feasibility study will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team.

The Royal College of Psychiatrists (RCPsych) requires access data from the MHSDS to establish whether, in future years of the audit, it can move to a system that will be entirely based on secondary analysis of data already submitted to NHS England.

At present, audit data are collected in addition to routine data submitted to NHS England. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against the National Institute for Health and Care excellence (NICE) quality standards, the audit will cease to collect bespoke data items. Over time, the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS England i.e., using routinely collected data. This will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care.

Legal Basis Justification:

HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

HQIP rely on Article 9(2)(i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Although RCPsych have provided a process to opt-out of the audit, patients have not consented to data collected by Trusts as part of routine clinical practice being shared with us. Patients are people with mental health difficulties (including those who lack capacity to consent to care) and include the elderly, young people aged between 14 and 18 years old, and others who may be unable to consent (e.g., those with learning disabilities and other vulnerable groups).

RCPsych have applied for and been granted Section 251 approval to collect identifiable data from Trusts for use in the feasibility study. The data being collected by the audit, and those requested from the MHSDS have been identified as necessary to assess the performance of Trusts against the audit standards. These are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard and were agreed by the NCAP Steering Group as necessary to assess quality of care.

The data collected by RCPsych for the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the pseudonymised data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit. Only pseudonymised data will be compared so there will be no risk of re-identifying individuals who have opted out of the NHS England data flow.

NCAP is a three-year improvement programme which commenced in 2016 to increase the quality of care that NHS Mental Health Trusts in England and Health Boards in Wales provide to people with psychosis.

Commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England, NCAP is the next phase in the development of the National Audit of Schizophrenia which took place 2011-2014.

NCAP is a three year programme with a 2 year extension which is commissioned until July 2022. However, The Royal College of Psychiatrists (RCPsych) commenced the new contract for the NCAP on 01 August 2022 which runs until 31 July 2025.

In 2019/2020 there were three projects:

1) The feasibility study, comparing data collected as part of the case-note audit with data from MHSDS; this work awaits the delivery of the dataset which is the subject of this request, comprising the 2016-2019 data and the 2017-2020 data both from MHSDS as detailed

2) Case-note audit, collecting data to analyse against the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. The 2019/20 audit has been completed and publication of the national and local reports took place in 2020. For the 2020/21 audit, data analysis has been completed, the report submitted, and is currently awaiting publication.

3) Service user survey, collecting information from people treated by EIP services to understand more about their experience of care. This service user survey has been completed and included in the 2020 national report.

RCPsych propose to examine the impact that the quality of care that people receive has on their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable RCPsych to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health.

The MHSDS data RCPsych are accessing was used for the feasibility study.

The cohort consists of patients aged 18 – 65 with First Episode Psychosis (FEP) on the caseload of an EIP team for 6 months or more on the census date (01/04/2019) and still on the caseload in June 2019 when the list of patients is submitted to the NCAP team for sampling. The cohort includes up to 100 patients for each of the 154 EIP teams in England. This is those patients included in the sample for the case-note audit and for whom RCPsych have collected audit data. The age range of 18-65 is being requested as these are the age range treated by EIP teams and included in the sample.

This Agreement covers access to the MHSDS dataset for the cohort of patients included in the sample for the NCAP case-note audit 2019/2020, the maximum cohort size is 10560 and may be reduced if anyone who has opted out since the data was received from Trusts. The data collected by RCPsych in the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams, allowing comparison of the datasets to test reliability.

RCPsych provided NHS England with the patient identifiers (NHS number, Postcode, Date of Birth, gender and NCAP ID) and NHS England provided the MHSDS data including the NCAP ID as a pseudonymised file for this cohort back to RCPysch.

The MHSDS data was pseudonymised (the data was returned to RCPsych with NCAP ID). This allowed RCPsych to compare the data to those collected for the case note audit. RCPsych needed to do this at a patient-level, in order to understand the reliability of the MHSDS data.

Data returned to NHS England included Year of birth, ethnicity, gender, employment status

Data on treatment by EIP team:

• Offer, referral, take up or refusal of Cognitive Behavioural Therapy for Psychosis

• Offer, referral, take up or refusal of Family Intervention

• Offer, take up or refusal of clozapine

• Physical health screening

o Comprehensive physical health assessment including screening of the following parameters within 12 weeks of acceptance on the caseload: Smoking status, lifestyle (incl. exercise, diet, alcohol and drug use), body mass index (BMI), blood pressure, glucose regulation (Glycated haemoglobin or HbA1c, Fasting plasma glucose, random plasma glucose), blood lipids (Total cholesterol measurement, Total cholesterol: HDL ratio measurement, non-HDL cholesterol, QRisk score – offer, take up or refusal

o Repeat physical health assessment one year after the first assessment (+/- 6 weeks) of all parameters above – offer, take up or refusal

o For anyone on the caseload for more than one year, annual comprehensive physical health assessment (all parameters above) carried out in the previous 12 months – offer, take up or refusal

• Physical health interventions

o Patients identified as needing an intervention (in the Lester Red Zone) as per screening above

o Referral to another service for, or interventions offered, taken up or refused by those patients needing an intervention

• Education and Employment Support offer, referral, take up or refusal

• Carer-focused support offer, referral, take up or refusal

• Outcome measures

o Whether there are baseline and follow up scores for two or more outcome measures

o Baseline and follow up scores for outcome measures (Health of the Nation Outcome Scales/ Health of the Nation Outcome Scales for Children and Adolescents, DIALOG (a Patient Reported Outcome Measure developed for people with psychosis), Process of Recovery Questionnaire, Other)

RCPsych require MHSDS package 1d in order to cover all data collected by the audit. The MHSDS contains record level data about care of young people and adults who are in contact with mental health, learning disabilities or autism spectrum disorder services and Mental Health Services Mental Health services : Community is separated into 4 packages

1a. Community Activity Basic this extract will provide basis administrative data to support analysis of local level community activity.

1b Community Activity plus clinical detail – everything in 1a plus clinical information diagnoses, interventions, assessments – recorded using clinical terminology, including SNOMED

1c. Community Activity plus patient details – everything on 1 plus information about the patients being treated and the care coordination and care plan arrangements

1d. Community Activity – admin data, clinical data demographics in one package.

RCPsych have received MHSDS data from 01 November 2016 onwards. This is because most questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016 and RCPsych need information on all interventions provided to accurately compare the data.

In addition, the purpose of the renewal under the previous iteration of the agreement, was to request additional data, from 1 November 2017-31 October 2020. This is to compare with the data collected by the audit for the 2020/21 EIP audit. This second comparison will strengthen the study and will allow some preliminary assessment of whether the routine data is becoming more comparable over time.

Data was requested for the cohort which comes from all EIP teams in England. This is because the reliability of MHSDS data will vary between Trusts, and it is important to understand how each trust performs. In future years of the audit, it may be possible for some Trusts to use data submitted to MHSDS rather than having to submit separate data to the audit, where the feasibility study shows that the data submitted to MHSDS is shown to be reliable enough for analysis against the audit standards.

The feasibility study is the only way to determine the reliability of the data for audit purposes. This was agreed following a preparatory meeting to discuss the form of the NCAP EIP audit with stakeholders from NHS England, clinicians from EIP services and HQIP, and HQIP’s contract with RCPsych was amended accordingly.

RCPsych thoroughly reviewed the options as part of the process for Section 251 approval, and this was deemed the best way to assess the reliability of the use of MHSDS in clinical audit.

RCPsych asked NHS England if it would be possible to just receive those items from the MHSDS needed for the feasibility study, however, were informed that it was only possible to receive the full packages. As the data required spans clinical information on assessments and interventions, patient details (including demographics and employment status).

The MHSDS for patients on the caseload of EIP teams includes the same data as those collected by RCPsych for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the NCAP EIP audit in 2019/2020. The purpose of this renewal is to also request an update, consisting of the MHSDS dataset, package 1d, from October 2017-October 2020, to improve comparison and strengthen the study.

It is not possible to use anonymous data. RCPsych need to ensure that RCPsych are comparing the data submitted for the audit to those held in the MHSDS for each patient.

The data was limited to people being treated by EIP teams.

RCPsych required all those episodes related to their treatment by or referrals made for them by EIP teams.

RCPsych needed to know if people were pregnant or gave birth within 6 weeks of 31/10/2019 as this affects whether the audit collects a record of weight and information about glucose. RCPsych would not require the unborn child or neonatal records.

RCPsych initially requested data from 01 November 2016 to 31 October 2019 and later requested a renewal of data related to the period 01 November 2017-31 October 2020, for comparison to the 2020/21 audit, for the reasons given above.

RCPsych need those fields related to their treatment by EIP teams in regard to the NCAP audit standards, which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych have been advised that the MHSDS data is only available as a package – RCPsych require 1d in order to cover all data collected by the audit, which includes clinical information on assessments and interventions and patient details (including demographics and employment status).

RCPsych provided identifiable data and NCAP ID (study ID) to NHS England, but did not require identifiable data to be returned with the MHSDS file. Instead, the data was provided in a pseudonymised file with the NCAP ID.

RCPsych only requested the MHSDS data for the cohort.

This agreement has Joint Data Controllers of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. NCAP is commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. Representatives from NHS England and HQIP sit on the NCAP advisory board; RCPsych also have regular contract review meetings with HQIP.

The Data Processor is the Royal College of Psychiatrists (RCPsych). The RCPsych also have sub-contracts for data processing with Netsolving Case Capture, Egress Technologies and Azure. Netsolving Case Capture provide the online platform upon which clinical audit data is uploaded and presented. Their role entails processing pseudonymised, record level, MHSDS data and displaying it back to Trusts in an aggregated format via an online portal accessed using unique usernames and passwords. Egress Technologies provide the secure environment for EIP teams so submit their eligible sample, with opt-outs already removed, comprised of identifiable data. Azure then provide the secure server where the RCPsych will download the pseudonymised information for storage.

The NCAP Steering Group acts as an advisory group and provides advice and guidance on:

• Final formulation of the audit standards, taken from the NICE and other relevant, evidence-based guidelines.

• Measurement tools and approaches that are most appropriate for measuring practice and outcomes against the audit standards.

• Marketing and promotion to ensure maximum sign-up to the audit and dissemination of the findings.

• Amendments and development of audit methodology.

• Interpretation and reporting of the audit data and findings.

• Recommendations from the audit to improve practice.

• Follow-up work between iterations of the audit

The Steering Group meets twice yearly and includes representatives from the following organisations, as well as experts by experience and local audit representatives:

British Psychological Society; Care Quality Commission; Early Intervention in Psychosis Network, Healthcare Quality Improvement Partnership (HQIP), NHS England, Welsh Government, Royal College of Nursing, Rethink Mental Illness, National Collaborating Centre for Mental Health, Royal College of General practitioners, Rethink Mental Illness are also contracted to provide advisory services and services related to service user engagement, including the production of a lay audit report.

Under v1 of this agreement, the data was not disseminated until 7th December 2021. Therefore, an extension was granted to allow time to carry out the analysis on this data and collate the feasibility report

In terms of the data that the RCPsych have received to date this was used to produce a feasibility report for HQIP and NHSE. Data was collected with the aim of seeing how reliably the NCAP audit data matches to routine data collected on the Mental Health Services Dataset (MHSDS). The analysis in the report examined the strength of agreement between equivalent data collected from both databases. This report contains aggregated data with small numbers suppressed for all of England for each data item and all data included is anonymous. This report was disseminated to the NCAP project team based at the RCPsych, HQIP, NHSE and members of the NCAP steering group.

For the new contract of NCAP the RCPsych have been commissioned to move the audit away from collecting bespoke data and only use routinely collected data. The data the RCPsych have received to date was used in the feasibility study with the aim of seeing how reliably the NCAP audit data matches to routine data collected on the MHSDS. The analysis in the report examined the strength of agreement between equivalent data collected from both databases. This has given the NCAP a baseline of how reliably data on the MHSDS can be used to demonstrate audit performance and areas where there is the most need to drive up the quality of reporting.

The National Clinical Audit of Psychosis (NCAP) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with psychosis with high quality data on the process and outcomes of NHS care.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

The Royal College of Psychiatrists (RCPsych) are making an application for access to the Mental Health Services Data Set (MHSDS). This is to carry out a feasibility study into the use of routine data for the audit in the future.

With the support of colleagues in NHS England and NHS Digital, RCPsych are aiming to move from a system that relies on clinical teams entering pseudonymous data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England already submit to NHS Digital as part of the MHSDS. The feasibility study will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team.

The Royal College of Psychiatrists (RCPsych) requires access data from the MHSDS to establish whether, in future years of the audit, it can move to a system that will be entirely based on secondary analysis of data already submitted to NHS Digital.

At present, audit data are collected in addition to routine data submitted to NHS Digital. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against the National Institute for Health and Care excellence (NICE) quality standards, the audit will cease to collect bespoke data items. Over time, the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS Digital i.e., using routinely collected data. This will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care.

Legal Basis Justification:

HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Although RCPsych have provided a process to opt-out of the audit, patients have not consented to data collected by Trusts as part of routine clinical practice being shared with us. Patients are people with mental health difficulties (including those who lack capacity to consent to care) and include the elderly, young people aged between 14 and 18 years old, and others who may be unable to consent (e.g., those with learning disabilities and other vulnerable groups).

RCPsych have applied for and been granted Section 251 approval to collect identifiable data from Trusts for use in the feasibility study. The data being collected by the audit, and those requested from the MHSDS have been identified as necessary to assess the performance of Trusts against the audit standards. These are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard and were agreed by the NCAP Steering Group as necessary to assess quality of care.

The data collected by RCPsych for the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the pseudonymised data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit. Only pseudonymised data will be compared so there will be no risk of re-identifying individuals who have opted out of the NHS Digital data flow.

NCAP is a three-year improvement programme which commenced in 2016 to increase the quality of care that NHS Mental Health Trusts in England and Health Boards in Wales provide to people with psychosis.

Commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England, NCAP is the next phase in the development of the National Audit of Schizophrenia which took place 2011-2014.

NCAP is a three year programme with a 2 year extension which is commissioned until July 2022.

In 2019/2020 there were three projects:

1) The feasibility study, comparing data collected as part of the case-note audit with data from MHSDS; this work awaits the delivery of the dataset which is the subject of this request, comprising the 2016-2019 data and the 2017-2020 data both from MHSDS as detailed

2) Case-note audit, collecting data to analyse against the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. The 2019/20 audit has been completed and publication of the national and local reports took place in 2020. For the 2020/21 audit, data analysis has been completed, the report submitted, and is currently awaiting publication.

3) Service user survey, collecting information from people treated by EIP services to understand more about their experience of care. This service user survey has been completed and included in the 2020 national report.

RCPsych propose to examine the impact that the quality of care that people receive has on their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable RCPsych to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health.

The MHSDS data RCPsych are seeking to access will be used for the feasibility study.

The cohort consists of patients aged 18 – 65 with First Episode Psychosis (FEP) on the caseload of an EIP team for 6 months or more on the census date (01/04/2019) and still on the caseload in June 2019 when the list of patients is submitted to the NCAP team for sampling. The cohort includes up to 100 patients for each of the 154 EIP teams in England. This is those patients included in the sample for the case-note audit and for whom RCPsych have collected audit data. The age range of 18-65 is being requested as these are the age range treated by EIP teams and included in the sample.

This Agreement covers access to the MHSDS dataset for the cohort of patients included in the sample for the NCAP case-note audit 2019/2020, the maximum cohort size is 10560 and may be reduced if anyone who has opted out since the data was received from Trusts. The data collected by RCPsych in the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams, allowing comparison of the datasets to test reliability.

RCPsych will provide NHS Digital with the patient identifiers (NHS number, Postcode, Date of Birth, gender and NCAP ID) and NHS Digital will provide the MHSDS data including the NCAP ID as a pseudonymised file for this cohort back to RCPysch.

The MHSDS data will be pseudonymised (the data will be returned to RCPsych with NCAP ID). This will allow RCPsych to compare the data to those collected for the case note audit. RCPsych need to do this at a patient-level, in order to understand the reliability of the MHSDS data.

Data returned NHS Digital will include Year of birth, ethnicity, gender, employment status

Data on treatment by EIP team:

• Offer, referral, take up or refusal of Cognitive Behavioural Therapy for Psychosis

• Offer, referral, take up or refusal of Family Intervention

• Offer, take up or refusal of clozapine

• Physical health screening

o Comprehensive physical health assessment including screening of the following parameters within 12 weeks of acceptance on the caseload: Smoking status, lifestyle (incl. exercise, diet, alcohol and drug use), body mass index (BMI), blood pressure, glucose regulation (Glycated haemoglobin or HbA1c, Fasting plasma glucose, random plasma glucose), blood lipids (Total cholesterol measurement, Total cholesterol: HDL ratio measurement, non-HDL cholesterol, QRisk score – offer, take up or refusal

o Repeat physical health assessment one year after the first assessment (+/- 6 weeks) of all parameters above – offer, take up or refusal

o For anyone on the caseload for more than one year, annual comprehensive physical health assessment (all parameters above) carried out in the previous 12 months – offer, take up or refusal

• Physical health interventions

o Patients identified as needing an intervention (in the Lester Red Zone) as per screening above

o Referral to another service for, or interventions offered, taken up or refused by those patients needing an intervention

• Education and Employment Support offer, referral, take up or refusal

• Carer-focused support offer, referral, take up or refusal

• Outcome measures

o Whether there are baseline and follow up scores for two or more outcome measures

o Baseline and follow up scores for outcome measures (Health of the Nation Outcome Scales/ Health of the Nation Outcome Scales for Children and Adolescents, DIALOG (a Patient Reported Outcome Measure developed for people with psychosis), Process of Recovery Questionnaire, Other)

RCPsych require MHSDS package 1d in order to cover all data collected by the audit. The MHSDS contains record level data about care of young people and adults who are in contact with mental health, learning disabilities or autism spectrum disorder services and Mental Health Services Mental Health services : Community is separated into 4 packages

1a. Community Activity Basic this extract will provide basis administrative data to support analysis of local level community activity.

1b Community Activity plus clinical detail – everything in 1a plus clinical information diagnoses, interventions, assessments – recorded using clinical terminology, including SNOMED

1c. Community Activity plus patient details – everything on 1 plus information about the patients being treated and the care coordination and care plan arrangements

1d. Community Activity – admin data, clinical data demographics in one package.

RCPsych are requesting MHSDS data from 01 November 2016 onwards. This is because most questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016 and RCPsych need information on all interventions provided to accurately compare the data.

In addition, the purpose of this renewal is to request additional data, from 1 November 2017-31 October 2020. This is to compare with the data collected by the audit for the 2020/21 EIP audit. This second comparison will strengthen the study and will allow some preliminary assessment of whether the routine data is becoming more comparable over time.

Data is requested for the cohort which comes from all EIP teams in England. This is because the reliability of MHSDS data will vary between Trusts, and it is important to understand how each trust performs. In future years of the audit, it may be possible for some Trusts to use data submitted to MHSDS rather than having to submit separate data to the audit, where the feasibility study shows that the data submitted to MHSDS is shown to be reliable enough for analysis against the audit standards.

The feasibility study is the only way to determine the reliability of the data for audit purposes. This was agreed following a preparatory meeting to discuss the form of the NCAP EIP audit with stakeholders from NHS England, NHS Digital, clinicians from EIP services and HQIP, and HQIP’s contract with RCPsych was amended accordingly.

RCPsych thoroughly reviewed the options as part of the process for Section 251 approval, and this was deemed the best way to assess the reliability of the use of MHSDS in clinical audit.

RCPsych asked NHS Digital if it would be possible to just receive those items from the MHSDS needed for the feasibility study, however, were informed that it was only possible to receive the full packages. As the data required spans clinical information on assessments and interventions, patient details (including demographics and employment status).

The MHSDS for patients on the caseload of EIP teams includes the same data as those collected by RCPsych for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the NCAP EIP audit in 2019/2020. The purpose of this renewal is to also request an update, consisting of the MHSDS dataset, package 1d, from October 2017-October 2020, to improve comparison and strengthen the study.

It is not possible to use anonymous data. RCPsych need to ensure that RCPsych are comparing the data submitted for the audit to those held in the MHSDS for each patient.

The data are limited to people being treated by EIP teams.

RCPsych require all those episodes related to their treatment by or referrals made for them by EIP teams.

RCPsych would need to know if people were pregnant or gave birth within 6 weeks of 31/10/2019 as this affects whether the audit collects a record of weight and information about glucose. RCPsych would not require the unborn child or neonatal records.

RCPsych initially requested data from 01 November 2016 to 31 October 2019 and later requested a renewal of data related to the period 01 November 2017-31 October 2020, for comparison to the 2020/21 audit, for the reasons given above.

RCPsych need those fields related to their treatment by EIP teams in regard to the NCAP audit standards, which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych have been advised that the MHSDS data is only available as a package – RCPsych require 1d in order to cover all data collected by the audit, which includes clinical information on assessments and interventions and patient details (including demographics and employment status).

RCPsych are providing identifiable data and NCAP ID (study ID) to NHS Digital, but do not require identifiable data to be returned with the MHSDS file. Instead, the data will be provided in a pseudonymised file with the NCAP ID.

RCPsych are only requesting the MHSDS data for the cohort.

This agreement has Joint Data Controllers of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. NCAP is commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. Representatives from NHS England and HQIP sit on the NCAP advisory board; RCPsych also have regular contract review meetings with HQIP.

The Data Processor is the Royal College of Psychiatrists (RCPsych). RCPsych has sub-contracts for data processing with Formic Ltd (who provide the software used to collect audit data from providers) and Azure (who provide the secure server where RCPsych will be storing identifiable data).

The NCAP Steering Group acts as an advisory group and provides advice and guidance on:

• Final formulation of the audit standards, taken from the NICE and other relevant, evidence-based guidelines.

• Measurement tools and approaches that are most appropriate for measuring practice and outcomes against the audit standards.

• Marketing and promotion to ensure maximum sign-up to the audit and dissemination of the findings.

• Amendments and development of audit methodology.

• Interpretation and reporting of the audit data and findings.

• Recommendations from the audit to improve practice.

• Follow-up work between iterations of the audit

The Steering Group meets twice yearly and includes representatives from the following organisations, as well as experts by experience and local audit representatives:

British Psychological Society; Care Quality Commission; Early Intervention in Psychosis Network, Healthcare Quality Improvement Partnership (HQIP), NHS England, Welsh Government, Royal College of Nursing, Rethink Mental Illness, National Collaborating Centre for Mental Health, Royal College of General practitioners, Rethink Mental Illness are also contracted to provide advisory services and services related to service user engagement, including the production of a lay audit report.

Under the previous iteration of this agreement, the data was not disseminated until 7th December 2021. Therefore, an extension is being requested to allow time to carry out the analysis on this data and collate the feasibility report. The expected outputs listed below remain the same.

A feasibility report will be produced for NHS England and will include the results of the comparison of the MHSDS data with the audit data and recommendations on the degree of reliability necessary for future use of the MHSDS in clinical audit. It will present aggregate data with small numbers suppressed in line with NHS Digital Guidance. Anonymised record level comparisons may be made available if more detailed information is required on any elements (i.e., it might be that some areas of data are found to be more reliable than others and so could be used in the audit in the future, while Trusts continue to submit separate case-note audit data in other areas).

At present this is the only communication planned. However, NHS England may want to engage with Trusts using the results of the feasibility report in order to encourage submission of complete data to MHSDS with the goal to move away from separate submission of case-note audit in the future. NCAP will support this as required. For example, RCPsych have previously presented to EIP regional groups on the results of the audit, and the NCAP clinical advisor presented in an NHS England webinar.

This report is due to be provided to HQIP by the end of the current contract, 31 July 2022. It is not expected that the MHSDS data be used for anything except carrying out the feasibility study.

As the data was disseminated on 7th December 2021, this analysis has only just commenced, so the benefits have not yet been yielded. The expected benefits of this piece of work remain the same. The data from the NCAP audit is currently in the process of being linked to the data items in the MHSDS which will allow for a comparison as to whether they can be reliably matched.

The National Clinical Audit of Psychosis (NCAP) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with psychosis with high quality data on the process and outcomes of NHS care.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

The Royal College of Psychiatrists (RCPsych) are making an application for access to the Mental Health Services Data Set (MHSDS). This is to carry out a feasibility study into the use of routine data for the audit in the future.

With the support of colleagues in NHS England and NHS Digital, RCPsych are aiming to move from a system that relies on clinical teams entering pseudonymous data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England already submit to NHS Digital as part of the MHSDS. The feasibility study will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team.

The Royal College of Psychiatrists (RCPsych) requires access data from the MHSDS to establish whether, in future years of the audit, it can move to a system that will be entirely based on secondary analysis of data already submitted to NHS Digital.

At present, audit data are collected in addition to routine data submitted to NHS Digital. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against the National Institute for Health and Care excellence (NICE) quality standards, the audit will cease to collect bespoke data items. Over time, the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS Digital i.e., using routinely collected data. This will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care.

Legal Basis Justification:

HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Although RCPsych have provided a process to opt-out of the audit, patients have not consented to data collected by Trusts as part of routine clinical practice being shared with us. Patients are people with mental health difficulties (including those who lack capacity to consent to care) and include the elderly, young people aged between 14 and 18 years old, and others who may be unable to consent (e.g., those with learning disabilities and other vulnerable groups).

RCPsych have applied for and been granted Section 251 approval to collect identifiable data from Trusts for use in the feasibility study. The data being collected by the audit, and those requested from the MHSDS have been identified as necessary to assess the performance of Trusts against the audit standards. These are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard and were agreed by the NCAP Steering Group as necessary to assess quality of care.

The data collected by RCPsych for the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the pseudonymised data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit. Only pseudonymised data will be compared so there will be no risk of re-identifying individuals who have opted out of the NHS Digital data flow.

NCAP is a three-year improvement programme which commenced in 2016 to increase the quality of care that NHS Mental Health Trusts in England and Health Boards in Wales provide to people with psychosis.

Commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England, NCAP is the next phase in the development of the National Audit of Schizophrenia which took place 2011-2014.

NCAP was originally a three year programme commissioned until April 2020. This has now been granted a two year extension; RCPsych have received confirmation from HQIP that the contract will be renewed for the two year extension period.

In 2019/2020 there were three projects:

1) The feasibility study, comparing data collected as part of the case-note audit with data from MHSDS; this work awaits the delivery of the dataset which is the subject of this request, comprising the 2016-2019 data and the 2017-2020 data both from MHSDS as detailed

2) Case-note audit, collecting data to analyse against the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. The 2019/20 audit has been completed and publication of the national and local reports took place in 2020. For the 2020/21 audit, data analysis has been completed, the report submitted, and is currently awaiting publication.

3) Service user survey, collecting information from people treated by EIP services to understand more about their experience of care. This service user survey has been completed and included in the 2020 national report.

Once the contract is extended beyond April 2020, along with continuing to audit EIP services against agreed standards, RCPsych propose to examine the impact that the quality of care that people receive has on their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable RCPsych to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health.

The MHSDS data RCPsych are seeking to access will be used for the feasibility study.

The cohort consists of patients aged 18 – 65 with First Episode Psychosis (FEP) on the caseload of an EIP team for 6 months or more on the census date (01/04/2019) and still on the caseload in June 2019 when the list of patients is submitted to the NCAP team for sampling. The cohort includes up to 100 patients for each of the 154 EIP teams in England. This is those patients included in the sample for the case-note audit and for whom RCPsych have collected audit data. The age range of 18-65 is being requested as these are the age range treated by EIP teams and included in the sample.

This Agreement covers access to the MHSDS dataset for the cohort of patients included in the sample for the NCAP case-note audit 2019/2020, the maximum cohort size is 10560 and may be reduced if anyone who has opted out since the data was received from Trusts. The data collected by RCPsych in the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams, allowing comparison of the datasets to test reliability.

RCPsych will provide NHS Digital with the patient identifiers (NHS number, Postcode, Date of Birth, gender and NCAP ID) and NHS Digital will provide the MHSDS data including the NCAP ID as a pseudonymised file for this cohort back to RCPysch.

The MHSDS data will be pseudonymised (the data will be returned to RCPsych with NCAP ID). This will allow RCPsych to compare the data to those collected for the case note audit. RCPsych need to do this at a patient-level, in order to understand the reliability of the MHSDS data.

Data returned NHS Digital will include Year of birth, ethnicity, gender, employment status

Data on treatment by EIP team:

• Offer, referral, take up or refusal of Cognitive Behavioural Therapy for Psychosis

• Offer, referral, take up or refusal of Family Intervention

• Offer, take up or refusal of clozapine

• Physical health screening

o Comprehensive physical health assessment including screening of the following parameters within 12 weeks of acceptance on the caseload: Smoking status, lifestyle (incl. exercise, diet, alcohol and drug use), body mass index (BMI), blood pressure, glucose regulation (Glycated haemoglobin or HbA1c, Fasting plasma glucose, random plasma glucose), blood lipids (Total cholesterol measurement, Total cholesterol: HDL ratio measurement, non-HDL cholesterol, QRisk score – offer, take up or refusal

o Repeat physical health assessment one year after the first assessment (+/- 6 weeks) of all parameters above – offer, take up or refusal

o For anyone on the caseload for more than one year, annual comprehensive physical health assessment (all parameters above) carried out in the previous 12 months – offer, take up or refusal

• Physical health interventions

o Patients identified as needing an intervention (in the Lester Red Zone) as per screening above

o Referral to another service for, or interventions offered, taken up or refused by those patients needing an intervention

• Education and Employment Support offer, referral, take up or refusal

• Carer-focused support offer, referral, take up or refusal

• Outcome measures

o Whether there are baseline and follow up scores for two or more outcome measures

o Baseline and follow up scores for outcome measures (Health of the Nation Outcome Scales/ Health of the Nation Outcome Scales for Children and Adolescents, DIALOG (a Patient Reported Outcome Measure developed for people with psychosis), Process of Recovery Questionnaire, Other)

RCPsych require MHSDS package 1d in order to cover all data collected by the audit. The MHSDS contains record level data about care of young people and adults who are in contact with mental health, learning disabilities or autism spectrum disorder services and Mental Health Services Mental Health services : Community is separated into 4 packages

1a. Community Activity Basic this extract will provide basis administrative data to support analysis of local level community activity.

1b Community Activity plus clinical detail – everything in 1a plus clinical information diagnoses, interventions, assessments – recorded using clinical terminology, including SNOMED

1c. Community Activity plus patient details – everything on 1 plus information about the patients being treated and the care coordination and care plan arrangements

1d. Community Activity – admin data, clinical data demographics in one package.

RCPsych are requesting MHSDS data from 01 November 2016 onwards. This is because most questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016 and RCPsych need information on all interventions provided to accurately compare the data.

In addition, the purpose of this renewal is to request additional data, from 1 November 2017-31 October 2020. This is to compare with the data collected by the audit for the 2020/21 EIP audit. This second comparison will strengthen the study and will allow some preliminary assessment of whether the routine data is becoming more comparable over time.

Data is requested for the cohort which comes from all EIP teams in England. This is because the reliability of MHSDS data will vary between Trusts, and it is important to understand how each trust performs. In future years of the audit, it may be possible for some Trusts to use data submitted to MHSDS rather than having to submit separate data to the audit, where the feasibility study shows that the data submitted to MHSDS is shown to be reliable enough for analysis against the audit standards.

The feasibility study is the only way to determine the reliability of the data for audit purposes. This was agreed following a preparatory meeting to discuss the form of the NCAP EIP audit with stakeholders from NHS England, NHS Digital, clinicians from EIP services and HQIP, and HQIP’s contract with RCPsych was amended accordingly.

RCPsych thoroughly reviewed the options as part of the process for Section 251 approval, and this was deemed the best way to assess the reliability of the use of MHSDS in clinical audit.

RCPsych asked NHS Digital if it would be possible to just receive those items from the MHSDS needed for the feasibility study, however, were informed that it was only possible to receive the full packages. As the data required spans clinical information on assessments and interventions, patient details (including demographics and employment status).

The MHSDS for patients on the caseload of EIP teams includes the same data as those collected by RCPsych for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the NCAP EIP audit in 2019/2020. The purpose of this renewal is to also request an update, consisting of the MHSDS dataset, package 1d, from October 2017-October 2020, to improve comparison and strengthen the study.

It is not possible to use anonymous data. RCPsych need to ensure that RCPsych are comparing the data submitted for the audit to those held in the MHSDS for each patient.

The data are limited to people being treated by EIP teams.

RCPsych require all those episodes related to their treatment by or referrals made for them by EIP teams.

RCPsych would need to know if people were pregnant or gave birth within 6 weeks of 31/10/2019 as this affects whether the audit collects a record of weight and information about glucose. RCPsych would not require the unborn child or neonatal records.

RCPsych have requested data from 01 November 2016 to 31 October 2019. For the renewal, the updated data requested relates to the period 01 November 2017-31 October 2020, for comparison to the 2020/21 audit, for the reasons given above.

RCPsych need those fields related to their treatment by EIP teams in regard to the NCAP audit standards, which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych have been advised that the MHSDS data is only available as a package – RCPsych require 1d in order to cover all data collected by the audit, which includes clinical information on assessments and interventions and patient details (including demographics and employment status).

RCPsych are providing identifiable data and NCAP ID (study ID) to NHS Digital, but do not require identifiable data to be returned with the MHSDS file. Instead, the data will be provided in a pseudonymised file with the NCAP ID.

RCPsych are only requesting the MHSDS data for the cohort.

This agreement has Joint Data Controllers of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. NCAP is commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. Representatives from NHS England and HQIP sit on the NCAP advisory board; RCPsych also have regular contract review meetings with HQIP.

The Data Processor is the Royal College of Psychiatrists (RCPsych). RCPsych has sub-contracts for data processing with Formic Ltd (who provide the software used to collect audit data from providers) and Azure (who provide the secure server where RCPsych will be storing identifiable data).

The NCAP Steering Group acts as an advisory group and provides advice and guidance on:

• Final formulation of the audit standards, taken from the NICE and other relevant, evidence-based guidelines.

• Measurement tools and approaches that are most appropriate for measuring practice and outcomes against the audit standards.

• Marketing and promotion to ensure maximum sign-up to the audit and dissemination of the findings.

• Amendments and development of audit methodology.

• Interpretation and reporting of the audit data and findings.

• Recommendations from the audit to improve practice.

• Follow-up work between iterations of the audit

The Steering Group meets twice yearly and includes representatives from the following organisations, as well as experts by experience and local audit representatives:

British Psychological Society; Care Quality Commission; Early Intervention in Psychosis Network, Healthcare Quality Improvement Partnership (HQIP), NHS England, Welsh Government, Royal College of Nursing, Rethink Mental Illness, National Collaborating Centre for Mental Health, Royal College of General practitioners, Rethink Mental Illness are also contracted to provide advisory services and services related to service user engagement, including the production of a lay audit report.

At this point, due to the press of business that NHS Digital is dealing with, it has not yet been possible for the data requested in the previous agreement (expiry 18/03/2021) to be supplied. The Royal College of Psychiatrists have therefore not been able to begin the analysis and reporting activities detailed in this original application. Following discussion with NHS digital, the Royal College of Psychiatrists combine in this renewal a request for an additional update to the data originally requested, plus an extension of one year. DSPT and DPA details for data controllers and processors have been updated. The expected outputs listed below remain the same.

A feasibility report will be produced for NHS England and will include the results of the comparison of the MHSDS data with the audit data and recommendations on the degree of reliability necessary for future use of the MHSDS in clinical audit. It will present aggregate data with small numbers suppressed in line with NHS Digital Guidance. Anonymised record level comparisons may be made available if more detailed information is required on any elements (i.e., it might be that some areas of data are found to be more reliable than others and so could be used in the audit in the future, while Trusts continue to submit separate case-note audit data in other areas).

At present this is the only communication planned. However, NHS England may want to engage with Trusts using the results of the feasibility report in order to encourage submission of complete data to MHSDS with the goal to move away from separate submission of case-note audit in the future. NCAP will support this as required. For example, RCPsych have previously presented to EIP regional groups on the results of the audit, and the NCAP clinical advisor presented in an NHS England webinar.

This report is due to be provided to HQIP by the end of the current contract, 30 April 2022. It is not expected that the MHSDS data be used for anything except carrying out the feasibility study.

At present, due to the press of business NHS Digital is managing, the data requested under the previous version of this agreement has not yet been supplied. It has therefore not been possible the work detailed to have commenced, so no benefits have yet been yielded. The expected benefits of this piece of work remain the same.

The National Clinical Audit of Psychosis (NCAP) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with psychosis with high quality data on the process and outcomes of NHS care.

This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England.

The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing.

NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs.

NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties.

The Royal College of Psychiatrists (RCPsych) are making an application for access to the Mental Health Services Data Set (MHSDS). This is to carry out a feasibility study into the use of routine data for the audit in the future.

With the support of colleagues in NHS England and NHS Digital, RCPsych are aiming to move from a system that relies on clinical teams entering pseudonymous data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England already submit to NHS Digital as part of the MHSDS. The feasibility study will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team.

This application requests that the Royal College of Psychiatrists (RCPsych) access data from the MHSDS to establish whether, in future years of the audit, it can move to a system that will be entirely based on secondary analysis of data already submitted to NHS Digital.

At present audit data are collected in addition to routine data submitted to NHS Digital. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against the National Institute for Health and Care excellence (NICE) quality standards, the audit will cease to collect bespoke data items. Over time the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS Digital i.e. using routinely collected data. This will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care.

Legal Basis Justification:

HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services.

HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients.

NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance.

Although RCPsych have provided a process to opt-out of the audit, patients have not consented to data collected by Trusts as part of routine clinical practice being shared with us. Patients are people with mental health difficulties (including those who lack capacity to consent to care) and include the elderly, young people aged between 14 and 18 years old, and others who may be unable to consent (e.g. those with learning disabilities and other vulnerable groups).

RCPsych have applied for and been granted Section 251 approval to collect identifiable data from Trusts for use in the feasibility study. The data being collected by the audit, and those requested from the MHSDS have been identified as necessary to assess the performance of Trusts against the audit standards. These are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard and were agreed by the NCAP Steering Group as necessary to assess quality of care.

The data collected by RCPsych for the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit.

NCAP is a three-year improvement programme which commenced in 2016 to increase the quality of care that NHS Mental Health Trusts in England and Health Boards in Wales provide to people with psychosis.

Commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England, NCAP is the next phase in the development of the National Audit of Schizophrenia which took place 2011-2014.

NCAP is a three year programme, currently commissioned until April 2020, with a possible two year extension, RCPsych have received provisional confirmation from HQIP that the contract will be renewed for the two year extension period.

In 2019/2020 there are three projects:

1) The feasibility study, comparing data collected as part of the case-note audit with data from MHSDS.

2) Case-note audit, collecting data to analyse against the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard.

3) Service user survey, collecting information from people treated by EIP services to understand more about their experience of care.

Once the contract is extended beyond April 2020, along with continuing to audit EIP services against agreed standards, RCPsych propose to examine the impact that the quality of care that people receive has on their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable RCPsych to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health.

The MHSDS data RCPsych are seeking to access in this application will be used for the feasibility study.

Patients aged 18 – 65 with First Episode Psychosis (FEP) on the caseload of an EIP team for 6 months or more on the census date (01/04/2019) and still on the caseload in June 2019 when the list of patients is submitted to the NCAP team for sampling. Maximum 100 patients per team (random sample identified by NCAP team)

This application covers access to the MHSDS dataset for the cohort of patients included in the sample for the NCAP case-note audit 2019/2020, the maximum cohort size is 10560 and may be reduced if anyone who has opted out since the data was received from Trusts. The data collected by RCPsych in the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams, allowing comparison of the datasets to test reliability.

RCPsych will provide NHS Digital with the patient identifiers (NHS number, Postcode, Date of Birth, gender and NCAP ID) and NHS Digital will provide the MHSDS data including the NCAP ID as a pseudonymised file for this cohort back to RCPysch.

The MHSDS data will be pseudonymised (the data will be returned to RCPsych with NCAP ID). This will allow RCPsych to compare the data to those collected for the case note audit. RCPsych need to do this at a patient-level, in order to understand the reliability of the MHSDS data.

Data returned NHS Digital will include Year of birth, ethnicity, gender, employment status

Data on treatment by EIP team:

• Offer, referral, take up or refusal of Cognitive Behavioural Therapy for Psychosis

• Offer, referral, take up or refusal of Family Intervention

• Offer, take up or refusal of clozapine

• Physical health screening

o Comprehensive physical health assessment including screening of the following parameters within 12 weeks of acceptance on the caseload: Smoking status, lifestyle (incl. exercise, diet, alcohol and drug use), body mass index (BMI), blood pressure, glucose regulation (Glycated haemoglobin or HbA1c, Fasting plasma glucose, random plasma glucose), blood lipids (Total cholesterol measurement, Total cholesterol: HDL ratio measurement, non-HDL cholesterol, QRisk score – offer, take up or refusal

o Repeat physical health assessment one year after the first assessment (+/- 6 weeks) of all parameters above – offer, take up or refusal

o For anyone on the caseload for more than one year, annual comprehensive physical health assessment (all parameters above) carried out in the previous 12 months – offer, take up or refusal

• Physical health interventions

o Patients identified as needing an intervention (in the Lester Red Zone) as per screening above

o Referral to another service for, or interventions offered, taken up or refused by those patients needing an intervention

• Education and Employment Support offer, referral, take up or refusal

• Carer-focused support offer, referral, take up or refusal

• Outcome measures

o Whether there are baseline and follow up scores for two or more outcome measures

o Baseline and follow up scores for outcome measures (Health of the Nation Outcome Scales/ Health of the Nation Outcome Scales for Children and Adolescents, DIALOG (a Patient Reported Outcome Measure developed for people with psychosis), Process of Recovery Questionnaire, Other)

RCPsych require MHSDS package 1d in order to cover all data collected by the audit. The MHSDS contains record level data about care of young people and adults who are in contact with mental health, learning disabilities or autism spectrum disorder services and Mental Health Services Mental Health services : Community is separated into 4 packages

1a. Community Activity Basic this extract will provide basis administrative data to support analysis of local level community activity.

1b Community Activity plus clinical detail – everything in 1a plus clinical information diagnoses, interventions, assessments – recorded using clinical terminology, including SNOMED

1c. Community Activity plus patient details – everything on 1 plus information about the patients being treated and the care coordination and care plan arrangements

1d. Community Activity – admin data, clinical data demographics in one package.

RCPsych are requesting data from 01 November 2016 – 31 October 2019. This is because some interventions (ie Cognitive Behavioural Therapy for Psychosis) may have been provided when the person was first taken onto the caseload of the EIP service. People will have been on the caseload for up to 3 years at the end of data collection (31 October 2019).

Data is requested for the cohort which comes from all EIP teams in England. In future years of the audit, it may be possible for some Trusts to use data submitted to MHSDS rather than having to submit separate data to the audit, where the feasibility study shows that the data submitted to MHSDS is shown to be reliable enough for analysis against the audit standards.

The feasibility study is the only way to determine the reliability of the data for audit purposes. This was agreed following a preparatory meeting to discuss the form of the NCAP EIP audit with stakeholders from NHS England, NHS Digital, clinicians from EIP services and HQIP, and HQIP’s contract with RCPsych was amended accordingly.

RCPsych thoroughly reviewed the options as part of the process for Section 251 approval, and this was deemed the best way to assess the reliability of the use of MHSDS in clinical audit.

RCPsych asked NHS Digital if it would be possible to just receive those items from the MHSDS needed for the feasibility study, however were informed that it was only possible to receive the full packages. As the data required spans clinical information on assessments and interventions, patient details (including demographics and employment status).

The MHSDS for patients on the caseload of EIP teams includes the same data as those collected by RCPsych for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the NCAP EIP audit in 2019/2020.

It is not possible to use anonymous data. RCPsych need to ensure that RCPsych are comparing the data submitted for the audit to those held in the MHSDS for each patient.

RCPsych are requesting MHSDS data from 01 November 2016 onwards. This is because most questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016 and RCPsych need information on all interventions provided to accurately compare the data.

The cohort includes up to 100 patients for each of the 154 EIP teams in England. This is those patients included in the sample for the case-note audit and for whom RCPsych have collected audit data.

The cohort is from teams across England. This is because the reliability of MHSDS data will vary between Trusts, and it’s important to understand how each trust performs.

The cohort are limited to those aged from 18 – 65 years, as these are the age range treated by EIP teams and included in the sample.

The data are limited to people being treated by EIP teams.

RCPsych require all those episodes related to their treatment by or referrals made for them by EIP teams.

RCPsych would need to know if people were pregnant or gave birth within 6 weeks of 31/10/2019 as this affects whether the audit collects a record of weight and information about glucose. RCPsych would not require the unborn child or neonatal records.

RCPsych have requested data from 01 November 2016 to 31 October 2019. This is because questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016.

RCPsych need those fields related to their treatment by EIP teams in regard to the NCAP audit standards, which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych have been advised that the MHSDS data is only available as a package – RCPsych require 1d in order to cover all data The collected by the audit, which includes clinical information on assessments and interventions and patient details (including demographics and employment status).

RCPsych are providing identifiable data and NCAP ID (study ID) to NHS Digital, but do not require identifiable data to be returned with the MHSDS file. Instead, the data will be provided in a pseudonymised file with the NCAP ID.

RCPsych are only requesting the MHSDS data for the cohort.

This agreement has Joint Data Controller’s of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. NCAP is commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. Representatives from NHS England and HQIP sit on the NCAP advisory board; RCPsych also have regular contract review meetings with HQIP.

The Data Processor is the Royal College of Psychiatrists (RCPsych). RCPsych has sub-contracts for data processing with Formic Ltd (who provide the software used to collect audit data from providers) and Azure (who provide the secure server where RCPsych will be storing identifiable data).

The NCAP Steering Group acts as an advisory group and provides advice and guidance on:

• Final formulation of the audit standards, taken from the NICE and other relevant, evidence-based guidelines.

• Measurement tools and approaches that are most appropriate for measuring practice and outcomes against the audit standards.

• Marketing and promotion to ensure maximum sign-up to the audit and dissemination of the findings.

• Amendments and development of audit methodology.

• Interpretation and reporting of the audit data and findings.

• Recommendations from the audit to improve practice.

• Follow-up work between iterations of the audit

The Steering Group meets twice yearly and includes representatives from the following organisations, as well as experts by experience and local audit representatives:

British Psychological Society; Care Quality Commission; Early Intervention in Psychosis Network, Healthcare Quality Improvement Partnership (HQIP), NHS England, Welsh Government, Royal College of Nursing, Rethink Mental Illness, National Collaborating Centre for Mental Health, Royal College of General practitioners, Rethink Mental Illness are also contracted to provide advisory services and services related to service user engagement, including the production of a lay audit report.

A feasibility report will be produced for NHS England and will include the results of the comparison of the MHSDS data with the audit data and recommendations on the degree of reliability necessary for future use of the MHSDS in clinical audit. It will present aggregate data with small numbers suppressed in line with NHS Digital Guidance. Anonymised record level comparisons may be made available if more detailed information is required on any elements (i.e. it might be that some areas of data are found to be more reliable than others and so could be used in the audit in the future, while Trusts continue to submit separate case-note audit data in other areas).

At present this is the only communication planned. However, NHS England may want to engage with Trusts using the results of the feasibility report in order to encourage submission of complete data to MHSDS with the goal to move away from separate submission of case-note audit in the future. NCAP will support this as required. For example, RCPsych have previously presented to EIP regional groups on the results of the audit, and the NCAP clinical advisor presented in an NHS England webinar.

This report is due to be provided to HQIP by the end of the current contract, 30 April 2020. It is not expected that the MHSDS data be used for anything except carrying out the feasibility study.

Yielded Benefits is not a requirement for new applications.